1. Field of the Invention
The present invention relates to biologically active food supplements (additives) and is intended for treating androgen deficiency in women and for preventive action against the states associated with osteoporosis.
2. Description of Related Art
The problem of osteoporosis (reduction in the amount of calcium in the bone structures) is a common knowledge. In order to address this problem, calcium preparations are used based on calcium carbonate, calcium citrate, calcium gluconate, calcium aspartate, calcium ascorbate, calcium aminochelate, calcium fumarate, calcium succinate, calcium phosphate, calcium citrate and other compounds. It is known that calcium preparations are better assimilated in combination with vitamin D. Therefore, multiple drugs are known, for example, calcium gluconate tablets (registration number R No. 000140/02-2001 MZ RF), Calcium-D3 Nycomed tablets (registration number P No. 013478/01-2001), and the like.
The prior art preparations have the following drawbacks.    1) Unfortunately, all known preparations are directed only to increasing the ingress of calcium into the body rather than eliminating the reasons of the bones losing calcium.    2) When a calcium preparation is administered, calcium may enter not only the bones but also other organs and systems, in particular it may calcify concrements in the kidneys that leads to a malfunction of kidneys.
In other words, to treat osteoporosis with calcium preparations is as effective as trying to pour water into holed barrel. The ability of the body to assimilate calcium and to use the same as intended is believed to be more important than the amount of calcium entering the body.
On the other hand, it is known that an important role in preserving the density of the mineral bone stock in both young and elderly men is played by androgens, i.e. male sex hormones. A lower bone density and a higher incidence of bone fractures is observed in men suffering from hypogonadism (i.e. a reduced level of testosterone, a male sex hormone). A low testosterone level is considered one of the major causes of osteoporosis, i.e. lowered mineral bone density in men, and is hence a risk factor of fractures.
An average testosterone level in women is substantially lower than that in men so that even an insignificant decrease in the testosterone level leads to osteoporosis. This also explains why more women than men suffer from osteoporosis.
Also, testosterone is a primary androgen and as such is a precursor of estrogens. It is well known that women in the reproductive age need three sex hormones—estrogens, gestagens, and androgens. For the physiological process of aging in the postmenopausal period to run normally, two of them—estrogens and androgens are necessary. An opinion exists that disorders in the postmenopausal period are mainly caused by androgen deficiency. That the androgen receptors are present in practically all the organs and tissues of the woman's body—bone tissue, central nervous system, skin, vessels, fatty tissue, unstriated and striated muscles—argues for how badly androgens are necessary for women.
Female androgen deficiency results in the decrease of sexual drive, low mood, reduction of muscle mass, the decrease of the bone tissue density, and the decrease of the sense of well-being. A proper level of androgens may be of great importance in metabolic, psychological, and sexual functions in women. Naturally, the level of testosterone in adult male is between 300 and 1000 ng/dl, whereas in adult female it is, according to various authors, between 20-50 and 80-120 ng/dl, i.e. about one-tenth that for males. Consequently, even a moderate disorder in forming androgens and metabolism thereof may result in developing androgen-deficiency condition in females.
The main androgens in serum in females with a normal menstrual period are testosterone and dihydrotestosterone (DHT). Dehydroepiandrosterone-sulfate, dehydroepiandrosterone (DHEA) and androstenedione are considered prohormones because it is only their conversion into testosterone that shows their androgenic properties. Healthy females in their reproductive age produce 500 μg of testosterone daily (5% of its daily production in males). With age, the level of all androgens in females decreases substantially. For example, the level of total and free testosterone, androstenedione, and DHEA
With regard to osteoporosis, androgens (first of all, testosterone) influence the bony tissue both directly and indirectly. The direct influence of testosterone on the bony tissue is responsible for the differences in the structure of male and female skeletons. Testosterone indirectly affects the bone formation through estrogens, female sex hormones, which are formed from androgens under the action of enzyme aromatase. Since testosterone is the primary estrogen in males, a decrease in its secretion also leads to a decrease in the bone density.
Accordingly, men with diagnosed osteoporosis are supposed to undergo hormonal examination including tests for testosterone, estradiol and sex steroid-binding globulin. In turn, all men with a low content of sex hormones need to undergo densitometry with a view to detecting osteoporosis.
Various medicaments, such as calcium preparations, vitamins D, and bisphosphonates, are used for the treatment of decreased bone density and osteoporosis. However, it has been proved that such medicaments have a minimum efficiency given that the testosterone level is still low, because the proper assimilation of medicaments directed to repairing the bone density is ensured precisely by testosterone. Therefore, the treatment of the bone density disorders has to be comprehensive, directed to both compensating for a deficit (if any) in testosterone and administering of calcium preparations.
However, when reducing this theory to practice problems have been faced with the known preparations sustaining the testosterone level in the body (for example, testosterone propionate) since they all require the most stringent health control.
The reason is that testosterone preparations are referred to doping drugs and have a lot of negative effects on the human body. When testosterone comes from the outside, the production of its own testosterone in the human body further decreases. On the other hand, as shown above, the body is in constant need for the ingress of calcium.